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Dorsiflex (MEPHENOXALONE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Dorsiflex (generic name: MEPHENOXALONE) is a mephenoxalone drug. It is currently in Phase 2 development.

Dorsiflex works by interacting with a specific target in the body to produce its therapeutic effect.

Dorsiflex is a small molecule modality. It has been studied in clinical trials for various conditions, including Heel Pain Syndrome, Restless Leg Syndrome, and Sleep Disturbance, using interventions such as acupuncture and manual therapy.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameMEPHENOXALONE
Drug classmephenoxalone
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Unfortunately, the exact mechanism of action of Dorsiflex is not well understood, but it is thought to involve the modulation of neural activity to produce its effects. This can lead to changes in the way the brain processes information and responds to stimuli. More research is needed to fully understand how Dorsiflex works.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Dorsiflex

What is Dorsiflex?

Dorsiflex (MEPHENOXALONE) is a mephenoxalone drug.

How does Dorsiflex work?

Dorsiflex works by interacting with a specific target in the body to produce its therapeutic effect.

What is the generic name of Dorsiflex?

MEPHENOXALONE is the generic (nonproprietary) name of Dorsiflex.

What drug class is Dorsiflex in?

Dorsiflex belongs to the mephenoxalone class. See all mephenoxalone drugs at /class/mephenoxalone.

What development phase is Dorsiflex in?

Dorsiflex is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing